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Whitepaper: Is your informatics infrastructure ready to externalize R&D?

How to reduce R&D costs in a global marketplace while continuing to deliver competitive products

Changing Business Models

Across the market verticals of pharmaceuticals, consumer goods, energy, food & beverage and chemicals, a similar story plays out. Businesses are under constant pressure to control or reduce R&D costs while continuing to deliver novel, competitive products. This challenge is set against a backdrop of skyrocketing expenses, tougher regulation and increased competition from an expanding global marketplace.

Changing Business Models

Many successful businesses are choosing to go ‘lean’. The use of contract research organizations, joint ventures, academic partners and consortiums are on the rise as organizations try to innovate faster and reduce operational expenditure1.

Surveys reveal that many top R&D outsourcing decision makers acknowledge a rising trend of shifting internal resources to more strategic activities to improve performance, based on the drive to gain costs savings. But despite this, many concede that they lack a clear strategy in how these changes in business practices can be successfully implemented to achieve their desired benefits2.

Challenges with Outsourcing

The use of outsourcing is accelerating, and it is forecast to provide an ever-increasing portion of R&D capability for businesses. This shift from internal to external resourcing will have a profound impact on how teams coordinate and execute R&D projects, as organizations pivot from cross-departmental teams towards managing large, dynamic networks of internal resources and external partners. The shift from internal to external, or virtual, teams poses three significant challenges:

Barriers to Communication & Coordination

The problem is more complex than the simple fact teams will no longer be located at one fixed site. Working with external parties, differing languages, business cultures and a lack of shared informatics infrastructure for resource planning, content management and reviews, are all common hurdles to overcome.

The ability to quickly and securely integrate systems between multiple organizations is presently very limited, requiring virtual teams to rely on email or basic document exchange services like DropBox for sharing documents and protocol or final reports. Has the document been reviewed? Does key content get disseminated to key decision makers in a timely manner?

Security & IP Protection

The lack of shared informatics infrastructure poses more than just communication challenges, it also puts sensitive data at risk. With large distribution email lists, it’s easy to accidentally forward confidential information to the wrong individual. This can be especially damaging when working extensively with external parties. Keeping track of who should, or should not, have access to data and sensitive documents can also be a challenge with email. You also need to consider what happens when a contract terminates. Will that individual clear out their inbox? Who will oversee this process? Are you confident you have captured the latest reviewed versions of reports and all sensitive data for proper archiving?

Quality Assurance

Finally, the lack of shared infrastructure systems, such as electronic lab notebooks (ELNs), lab information management systems (LIMS) or scientific data management systems (SDMS), which are often the backbone of R&D organizations for data capture, validation and retention, means that someone within your organization may need to process all the files and documents and distribute them to each relevant corporate data repository. This is time consuming and introduces the potential for data loss or corruption, and usually necessitates several additional layers of overhead for review to ensure the accuracy of data.

Limitations of Existing Informatics Systems

The IDBS E-WorkBook ELN is our cloud-based enterprise ELN, which provides the critical data capture and management backbone of The IDBS E-WorkBook Cloud. E-WorkBook ELN captures all the information that a scientist generates, and stores it in a common repository, allowing easy but controlled access, focused searching, and data mining and reporting, across an entire organization.

User Training

Modern enterprise ELNs and LIMS are complex tools, often heavily configured for a particular business unit’s specific processes and defined use cases. Indeed, many organizations have multiple ELNs and LIMS deployed between departments or projects and struggle to harmonize these systems across internal teams. Users must be trained in both the usage policies and nuances of the software deployed, making it difficult and expensive to quickly onboard new users. Depending on the nature of the external partner, such onboarding may simply be a non-starter. While this type of investment may be appropriate for users participating in a long-term joint venture lasting months or years, it will not work for short-term transactional contracts, typically seen with contract research organizations (CROs). Many partner organizations are resistant to making this type of commitment, even with financial incentivizing and you can understand why: major CROs service hundreds of clients, making it cost-prohibitive to use each customer’s unique system of data entry.

User Access Controls

A second hurdle concerns handling third party identity management and record access. While most enterprise R&D informatics systems have robust user security features, these typically need to be configured and carefully managed, often by business owners. Onboarding new users often requires getting the user added to a corporate LDAP/ActiveDirectory system, or worse, issued with a PKI token from a third party provider.

Going through corporate IT to add a new collaborative partner can be time consuming and impractical for short-term contracts. New users must also be added to the enterprise R&D application, and it can be difficult to ensure that an external user is prevented from accessing any inappropriate data and functionality. Such security governance introduces a high burden of risk for system administrators.

The firewall and software access

Finally, corporate R&D applications are predominantly deployed within the private infrastructure of the business entity. For an external partner to gain access, they must be provided a means of accessing the corporate intranet and domain, typically via VPN.

External users must also be granted access to the software itself, which, more often than not, means downloading and installing a desktop client or accessing the application via Citrix or other, similar remote desktop applications. The business user is now responsible for additional software licensing and potentially remote software support.

Punching holes through the corporate firewall and granting third parties access to sensitive data makes CIOs nervous. And for good reason. Intellectual property (IP) theft is on the rise, and is often cited as a top concern for R&D corporate managers.

Given the many disadvantages and practical barriers to using existing corporate R&D informatics tools like ELNs and LIMS, is it really any wonder that most external collaborations are still run using email, SharePoint and Dropbox?

Defining a Better Environment for B2B Collaboration

Trends across business verticals indicate a shift in investment from internal assets and human resources to outsourced and collaborative R&D, and this is particularly evident in the healthcare and pharmaceuticals sectors. Emad and SharePoint are merely stop gaps, and are not adequate substitutes for the tools required to secure IP, ensure data quality and drive insight and decision making, if outsourcing trends continue as expected. We need to rethink how we manage projects and data to adapt to this new paradigm. But, where do we start?

System Accessibility

For R&D businesses to more readily embrace externalization and B2B collaboration, team leaders need to be able to quickly and easily establish secure collaborative environments and invite users from other organizations to form teams. Cloud-based services are ideally suited to this task.

Unlike traditional infrastructure and software licensing models, cloud-based services are designed to be activated quickly with elastic infrastructure, capable of scaling up or down on demand to meet business needs, in a highly cost-effective manner.

They offer modern user authentication models, using standards such as SAML and OAuth, to reduce the need for all users to be registered on a central parent corporate domain, which is critical when working with a large number of external partners, often on short-term contracts. They are also accessible from anywhere with internet access, and can be viewed using a range of devices or web browsers. The ability to ramp up projects, onboard users quickly, and the ubiquitous access via the internet and web browser compatibility, makes cloud-based services an ideal platform for B2B collaboration.

One of the common businesses objections to moving R&D data operations to the cloud is its perceived vulnerability. Can sensitive data really be secure on the cloud? The security of cloud services has now strengthened to the point where it is as secure, if not more secure, than traditional corporate infrastructure. This is evidenced by the fact that many companies are routinely using cloud-based service providers for their CRM and finance functions. In the healthcare domain, clinical data is frequently managed in the cloud by preference.

You need to remember that service providers are not all equal. Ensure that you select a vendor that can demonstrate routine penetration and vulnerability testing from a reputable external auditor. Your service provider should also provide guarantees for system availability, or be backed a large infrastructure provider such as Amazon Web Services (AWS) or Microsoft Azure.

Keep Things Simple

You can lead a horse to water, but can you make it drink? You’ve just launched your impressive new collaboration portal, but convincing your partners to use it may not be as simple as you think. The key is finding the right balance between features and ease of use. R&D outsourcing takes on many flavors, from long-term joint ventures and academia partnerships to short-term, high-turnover transaction-based contracts via a deep network of CROs/CMOs. To manage such a broad diversity of relationships requires tools that are simple to use and allow easy onboarding of new partners. They need to add little overhead but provide value for the partner. Think LIMS- and ELN-lite. If the application takes more than 15 minutes training to get started, and does not provide the means for user self-learn, it is likely to be too complex for efficient broad usage.

Fostering Communication

According to recent surveys, one of the top outsourcing concerns is communication. Effective communication on complex projects, where teams are dependent on the timely preparation and receipt of test articles, protocol approvals, data review and prompt decision-making, requires more than basic email contact. Have the samples been received? Has the study started? Is the report ready for review? Can we approve the release? Modern R&D operations have become dependent on sophisticated internal systems such as Inventory Management, LIMS and ELNs to provide logistical coordination, resource planning and services requesting, as well as a data review and approval processes.

Trust in the Data

Another major concern is quality assurance. This is a multifaceted problem. We know that any B2B collaboration environment must make document lifecycle management effortless and as transparent as possible. Good governance of the content, version and authorship are essential. This is vital for any document used to communicate primary data and results, such as final study reports that drive key decisions. Long-term partnerships often require the harmonizing of business processes, standard operating procedures (SOPs) and document templates for material preparation, method validation protocols, data analysis methodologies and data reporting.

Such documents are also typically version controlled, approved for release and need to be frequently revised and referenced. A collaboration environment should make content governance between businesses simple and transparent.

Support for Complex Data Types and Analytical Processes

For scientific R&D, basic document exchange is the most rudimentary level of collaboration. Scientific processes typically involve the manufacturing and testing of samples, which may contain material formulations, and chemical and biological entities. The production and testing of such articles creates specialist requirements that are not catered for by generic business collaborative platforms. These materials have properties and proprietary data formats that require specialized tools to edit and visualize their sophisticated contextual data, and provide registration services and searching capabilities. Larger outsourced projects may have hundreds, or even thousands, of these objects to track and manage. For scientific collaboration, the ability to natively handle these objects and data formats is highly desirable.

The complexity doesn’t stop with the testable objects themselves. Scientific testing involves sophisticated methodologies and the use of complex instrumentation. How a test is run and how an instrument is configured will have a profound effect on the testing outcomes and interpretation of data. The ability to share scientific protocols, equipment configuration parameters and complete datasets is essential.

Most R&D operations will have spent years of effort and substantial capital to automate and integrate method, data capture and reporting processes, using LIMS and ELNs, to improve lab efficiency and reduce reporting times.

Without shared informatics infrastructure, companies must reduce the process to the lowest common denominator: document-based reporting. When collaborating with external organizations, this creates a burden at both ends. The data producer must transcribe all pertinent information from their internal systems into a formal report. The data consumer must review the contents of this report and, if acceptable, may have to copy the data out of the report into their own internal systems. This wasteful duplication of effort introduces the substantial risk of data transcription error into the process3,4,5.

To reduce this burden and eliminate data transcriptions errors, virtualized teams need to work together in a shared environment with ELNs and/or LIMS-like capabilities to better streamline the review and approval methodology, test parameters and interim data in real time. To facilitate downstream processing, assay metadata and results should be presented using standardized formats that can be directly consumed by analysis and reporting tools of the data consumer’s choosing.

Data Extraction and Archiving

While cloud-based services are ideal environments for when a project is in flight, data must ultimately be extracted and moved into internal corporate repositories for dissemination and archiving. When choosing your cloud-based service provider, ensure they provide suitable web services and extension points to make the extraction of your project data simple, or preferably, automated. The last thing you need is to be stuck with a PDF or PowerPoint presentation and the onerous task of extracting the data out for repurposing.

The ability to directly integrate the cloud-based service provider with your corporate infrastructure provides a low-touch, low-risk, and highly efficient means of data transmission that will reduce your QC burden, reduce study completion and reporting times and free up your internal resources to spend time focusing on higher returning activities.

E-WorkBook Connect:
B2B Collaboration Platform for R&D from IDBS

It sounds simple, doesn’t it? Here’s a quick checklist of what you need to consider:

  • Look for a reputable cloud-based service provider capable of delivering a secure environment for B2B collaboration
  • The cloud-based environment should provide tools to foster communication to help coordinate activities, plan work and provide alerts for activity, review and commentary for in-flight projects
  • Look for more than a document ‘dump’. The environment should be scientifically aware, with tools to help with the management of test articles, scientific data formats, sharing protocols and data entry forms
  • The environment must make it simple to extract content from the collaboration cloud for direct automated insertion into your corporate systems for dissemination and final archiving
  • If your B2B partners (e.g. CROs) primarily focus more on delivering transactional services, keep it as simple as possible and identify tools that are the right size for the job

References

1 “2015 Outsourcing Survey”, Contract Pharma, 2015

2 “Outsourcing in the Pharmaceutical Industry”, KPMG, 2012 data.

3 Smyth ET, McIlvenny G, Barr JG, Dickson LM, Thompson IM.

Automated entry of hospital infection surveillance data Infect Control Hosp Epidemiol 1997;18:486-491 10

4 Jorgensen CK, Karlsmose B. Validation of automated forms processing. A comparison of Teleform with manual data entry. Comput Biol Med 1998;28:659-667 11

5 Weber BA, Yarandi H, Rowe MA, Weber JP. A comparison study:
paper-based versus web-based data collection and management Appl Nurs Res 2005;18:182-185

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